CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)
FDA 510(k) clearance K121441 · decided 2012-07-20
Clearance details
- K-number
- K121441
- Device name
- CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)
- Applicant
- Bovie Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-05-15
- Decision date
- 2012-07-20
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- HQP
- Device class
- 2
- Regulation number
- 886.4115
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Clearwater, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.